Mepolizumab for Eosinophilic Fasciitis
Primary Purpose
Eosinophilic Fasciitis
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mepolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Fasciitis focused on measuring Mepolizumab
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 18 years or older.
- History and physical examination consistent with EF
- Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
- Documented peripheral eosinophilia (≥500 microliter)
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Exclusion Criteria:
- Eosinophilic fascitis disease duration > 5 years
- Known history of adverse reaction to mepolizumab (Nucala)
- Pregnant females
- Females actively trying to conceive
- Vulnerable study population
- Asthma requiring inhaled cortiosteroids
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Patients with a biopsy proven diagnosis of eosinophilic fasciitis
Outcomes
Primary Outcome Measures
Modified Rodnan Skin Score (mRSS)
Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.
Secondary Outcome Measures
Localized Scleroderma Skin Severity Index (mLoSSI) score
Mean change before and after treatment. mLoSSI score quantifies disease activity.
Localized Scleroderma Damage Index (LoSDI) score.
Mean change before and after treatment. LoSDI score quantifies disease damage.
Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
Physician's Global Assessment of Disease Activity (PhysGA-A)
Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.
Physician's Global Assessment of Disease Damage (PhysGA-D)
Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.
Dermatology Quality of Life Index (DLQI)
Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
Patient Global Assessment of Disease Severity (PtGA-S)
Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by "not severe" at 0 and "very severe" at 100.
Full Information
NCT ID
NCT04305678
First Posted
March 10, 2020
Last Updated
February 13, 2023
Sponsor
Mayo Clinic
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT04305678
Brief Title
Mepolizumab for Eosinophilic Fasciitis
Official Title
Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding lost from Sponsor.
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
Detailed Description
This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Fasciitis
Keywords
Mepolizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Mepolizumab for the treatment of eosinophilic faciitis.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Patients with a biopsy proven diagnosis of eosinophilic fasciitis
Intervention Type
Drug
Intervention Name(s)
Mepolizumab
Other Intervention Name(s)
Nucala
Intervention Description
Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks
Primary Outcome Measure Information:
Title
Modified Rodnan Skin Score (mRSS)
Description
Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Localized Scleroderma Skin Severity Index (mLoSSI) score
Description
Mean change before and after treatment. mLoSSI score quantifies disease activity.
Time Frame
24 weeks
Title
Localized Scleroderma Damage Index (LoSDI) score.
Description
Mean change before and after treatment. LoSDI score quantifies disease damage.
Time Frame
24 weeks
Title
Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
Description
Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
Time Frame
24 weeks
Title
Physician's Global Assessment of Disease Activity (PhysGA-A)
Description
Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.
Time Frame
24 weeks
Title
Physician's Global Assessment of Disease Damage (PhysGA-D)
Description
Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.
Time Frame
24 weeks.
Title
Dermatology Quality of Life Index (DLQI)
Description
Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
Time Frame
24 weeks.
Title
Patient Global Assessment of Disease Severity (PtGA-S)
Description
Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by "not severe" at 0 and "very severe" at 100.
Time Frame
24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients 18 years or older.
History and physical examination consistent with EF
Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
Documented peripheral eosinophilia (≥500 microliter)
Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
Patients who read and sign an approved informed consent for this study
Exclusion Criteria:
Eosinophilic fascitis disease duration > 5 years
Known history of adverse reaction to mepolizumab (Nucala)
Pregnant females
Females actively trying to conceive
Vulnerable study population
Asthma requiring inhaled cortiosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason C Sluzevich, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Mepolizumab for Eosinophilic Fasciitis
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